3-year Study of Menostar Versus Evista to Prevent Osteoporosis in Post-menopausal Women
Phase 3
Completed
- Conditions
- Osteopenia
- Interventions
- Registration Number
- NCT00310531
- Lead Sponsor
- Bayer
- Brief Summary
The aim of this trial is to investigate whether the Menostar patch is as safe and effective in the prevention of bone loss in postmenopausal women as raloxifen, a drug already registered for prevention and treatment of osteoporosis.
- Detailed Description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 500
Inclusion Criteria
- Last (regular) menstrual period more than 5 years ago
- Relative good state of health
- Intact, normal uterus
Exclusion Criteria
- Bone and musculoskeletal diseases
- Clinically significant vertebral fracture within the last 12 months
- Pre-existing cardiovascular disease (e.g. uncontrolled high/low blood pressure, stroke, thromboembolic event etc)
- Uncontrolled diabetes mellitus (or treated with insulin)
- Uncontrolled thyroid disorders
- Relevant renal disorder or significant liver dysfunction (including cholestasis)
- History of alcohol or drug abuse
- History of immobilization of more than 2 months in the last 6 months
- Smoking of more than 10 cigarettes per day
- Unexplained uterine bleeding
- Known or suspected malignant or premalignant disease (e.g. cancer of breast or uterus, melanoma)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Menostar (Estradiol, BAY86-5435) - Arm 2 Raloxifene -
- Primary Outcome Measures
Name Time Method Percentage change in Bone Mineral Density at the lumbar spine after 3 years
- Secondary Outcome Measures
Name Time Method Percentage change in biochemical markers of bone turnover after 6 months Proportion of patients with hot flushes after 3 year Percentage change in Bone Mineral Density of the hip after 3 years Proportion of patients with an abnormal endometrial biopsy after 3 years Digital breast density analysis after 2 years Change in Women's Health Questionnaire after 2 years Pharmacogenetic analysis after 2 years